Kornimate/medical-research-clean huggingface dataset:
mapd: modifiable factors affecting propofol dosing

Conditions: Anesthesia

Summary: the investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug, propofol, required for anaesthetic induction.

the investigators hypothesise that modifiable environmental factors may cause reversible changes in a patients neurobiology which affect their responsiveness to anaesthetic drugs. such factors may include chronic caffeine intake, chronic sleep deprivation, acute anxiety about surgery, alcohol intake and smoking. investigation of the relationship between such factors and the dose of anaesthetic required for loss of consciousness may not only allow for better prediction of dose requirements but may also allow for optimisation of patients prior to undergoing general anaesthesia with a view to decreasing anaesthetic dose requirements and the complications associated with this. to address this questions, the investigators will be asking patients admitted for any day case surgery at chelsea \& westminster hospital to complete five short questionnaires and a demographic sheet addressing 1) caffeine intake 2) sleep habits 3) anxiety about the operation 4) alcohol intake 5) smoking status. this will then be compared to the amount of the anaesthetic drug propofol required and the time taken to induce loss of consciousness prior to surgery. loss of consciousness will be measured subjectively by loss of eye opening response and loss of verbal response when a patient is asked to count upwards from 1. the investigators also wish to investigate whether these same 5 factors affect patient reported postoperative pain and analgesia requirements. as such the investigators will also ask participants to rate their level of pain whilst at rest and whilst coughing at 1 hour after the operation. we will also record how much analgesia is requested and received in the postoperative period.

Eligibility criteria:
inclusion criteria: asa i or ii patients scheduled for elective day case general anaesthesia with laryngeal mask airway (lma) airway insertion and a standard propofol-fentanyl induction, aged between 18-65 years at chelsea \& westminster hospital. exclusion criteria 1. pregnancy 2. neurological disease 3. substance abuse 4. cardiac disease 5. renal disease 6. obesity additional exclusion criteria include: 1. any patient requiring adjunctive analgesia including local/epidural/spinal anaesthesia. 2. any patient requiring an anesthetic induction regime other than propofol-fentanyl (inc. administration of benzodiazepines or other strong opioids). 3. any patient who does not receive a standard anaesthetic induction regime due to clinical need

Keywords: propofol anaesthetic dose sleep caffeine anxiety induction
novel determinants and measures of smokeless tobacco use: study 2

Conditions: Tobacco Use Disorder; Nicotine Dependence

Summary: the research project will determine the level of nicotine in st products that will lead to the greatest reduction in toxicant exposure

this is a randomized, multi-site trial determining the effects of switching smokeless tobacco (st) users to lower toxicant st products which vary in nicotine levels on biomarkers of exposure and patterns of use. st users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower nnk plus nnn product with three different levels of nicotine) for a period of 8-weeks. follow-up will occur at 9 and 20 weeks.

Eligibility criteria:
inclusion criteria: 1. using a consistent and daily amount of st with specific nicotine and tobacco-specific nitrosamine (tsna) levels for the past year; 2. in good physical health (no unstable medical condition); 3. stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the dsm-iv criteria). exclusion criteria: 1. subjects must not be currently using other tobacco or nicotine products. 2. female subjects cannot be pregnant or nursing.

Keywords: biomarkers of tobacco exposure smokeless tobacco
tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (tpop): tpop-02 study

Conditions: Trauma; Posttraumatic Stress Disorder

Summary: the purpose of this study is to evaluate efficacy and safety of polyunsaturated fatty acid for the prevention of posttraumatic stress disorder (ptsd) in patients with accidental injuries.

accidental injuries, mostly motor vehicle accident, in civilian population are frequent events.for instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness and the major diagnoses are post-traumatic stress disorder (ptsd) and depressive disorder.omega-3 polyunsaturated fatty acid (omega-3 pufa) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries.we evaluate efficacy and safety of omega-3 pufa for the secondary prevention of posttraumatic stress disorder (ptsd) and related psychiatric illness in patients with accidental injury

Eligibility criteria:
inclusion criteria: 1. 18 plus years 2. a native japanese speaking ability 3. possibility to contact patients with injury in 240 hours, and dosing in oral use 4. physical and metal status to possible understands scope and contents in the trial and gets informed consent exclusion criteria: 1. clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging 2. cognitive impairment: mini mental state examination \< 24 3. heavy drinker or 100iu/l ≦ γgtp in administration 4. heavy smoker (over 40 cigarettes per day) 5. history and current suspicion in diagnosis of psychosis and bipolar i disorder 6. suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder 7. existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment 8. use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals 9. use of polyunsaturated fatty acid supplement within 3 month at regular intervals 10. habit of eating fish over 4 times per week

Keywords: patients with high-energy admitted intensive care unit motor vehicle accident falling from height other accident
dual implant versus single implant distal end of femur

Conditions: Femur Fracture

Summary: this research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.


Eligibility criteria:
inclusion criteria: * femur fracture distal to the femoral diaphysis. * operative treatment within 72 hours of presenting to the treating hospital. * patient was previously ambulatory. * fracture amendable to either single or dual implant fixation. * informed consent can be obtained from the patient, family member, or power of attorney. exclusion criteria: * associated major lower extremity fracture. * ongoing infection. * history of metabolic bone disease (paget's, etc). * pathologic fracture. * open fracture. * severe cognitive impairment (six item screener with 3 or more errors). * stage 5 parkinson's disease. * significant femoral bone loss requiring planned staged bone grafting. * vascular injury.
split-mouth study of a new flowable composite in non-carious cervical lesions

Conditions: Non-carious Cervical Lesions

Summary: the overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite tm flow for treatment of non-carious cervical lesions. each participant receives two different fillings (test- and control material) in two different teeth. the fillings are assessed according to selected fdi criteria at baseline (7-10 days after filling placement) and after 1, 6, 12, 24, 36 and 60 months.


Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * age: 18-65 years * 2 nccl needing treatment, comparable in extend and size, preferably located in different quadrants * vital teeth, regular sensitivity * sufficient language skills * no active periodontitis * preoperative vas values \< 3 regarding tooth sensitivity on biting. tooth sensitivity on temperature or touching (tooth brushing, probing) originating in the area of the nccl is accepted. * subject wishes to have a restoration as part of the study (written declaration of consent after detailed explanation) exclusion criteria: * not completed hygiene phase or poor oral hygiene * sufficient isolation of the cavity not possible * patients with a proven allergy to one of the ingredients (methacrylates) * patients with severe systemic diseases * periodontally insufficient dentition * pregnancy * part of the development project team of tm flow * staff of the study management team * staff of the internal clinic
evaluation of carebot ai mmg medical device for breast lesion detection and density assessment

Conditions: Breast Cancer; Breast Tumor Benign

Summary: comparison of accuracy of clinician and dlad image evaluation (carebot ai mmg v2.2) 1. comparison of the accuracy of density assessment by clinician and dlad (dens) 2. comparison of accuracy of lesion assessment by clinician and dlad (mass, class)

the mammography studies were acquired from three independent sites: site 1 (euc mamocentrum brno) and site 2 (hospital šumperk, a.s.) specialise in routine screening mammography, and site 3 (masaryk memorial cancer institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall). the ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively. for comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.

Eligibility criteria:
inclusion criteria: * the medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography. exclusion criteria: * the medical device cannot be used in patients with breast implants. * the medical device cannot be used in male breast examination. * the medical device cannot be used in patients under 18 years of age.
is the exhaled nitric oxide in infants a predictive marker of asthma ?

Conditions: Asthma

Summary: background: it seems that in the infants and the young children, the increase of the exhaled nitric oxide (eno) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke objective: the investigators objective is to bring to light that the rise of the eno, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.methods: once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. after allergic exploration (skin tests and assay of serum total and specific ige, complete blood count), the eno is measured by an off-line tidal breathing method using a chemiluminescence no analyzer. annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. after a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eno and the various clinical, biological and environmental parameters known to influence the variations of this marker. then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.

this study is a epidemiological observation study

Eligibility criteria:
inclusion criteria: * infant between 6 and 36 months * more than 3 wheezing episodes * questionary and biological assessment for recurrent wheeze * signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child) exclusion criteria: * infant with respiratory disease in neonatal period * infant with other obstructive pathology (cystic fibrosis, primary ciliary dyskinesia,...) * infant who have a respiratory infection less than 4 weeks * infant with asthma exacerbation or who still have corticosteroid treatment * infant without social security from their parents

Keywords: infants exhaled nitric oxide asthma tobacco smoke exposure environment
neuromuscular training in female youth soccer

Conditions: Injury;Sports

Summary: the goal of this clinical trial is to analyze the effectiveness of an nmt-based, injury prevention training program ('fifa 11+ for kids') in pre-adolescent (ages 8 to 11) elite female soccer players by measuring neuromuscular control and motor coordination through pre-intervention and post-intervention testing. as well as monitoring the incidence of injury throughout a soccer season.

this study will recruit females aged between 8-11 from several teams within a large, competitive elite soccer club. whole teams will be assigned to either the intervention group or an age-matched control group. participants will be informed which group they will be placed in prior to participation in the research study. as directed by their respective coaches, the intervention group will receive neuromuscular training (nmt) through an already established, validated protocol (fifa 11+ kids); whilst the control group will perform their standard warm-up during soccer practice sessions. the program will last for the duration of the spring soccer season (january - may 2023; 5 months). all study participants will be required to attend two evaluation sessions (pre-intervention and post-intervention) in order to measure performance in speed, agility, hop testing, dynamic balance and strength.

Eligibility criteria:
inclusion criteria: * elite female soccer players aged 8-11. * member of an elite youth soccer club. exclusion criteria: * female not aged 8-11 years old. * not a member of a youth soccer club. * unable to attend the pre-intervention or post-intervention evaluation, for reasons other than injury. * unable to attend 80% or more of scheduled training sessions. * if a participant discontinues playing soccer they will be excluded. * declines to participate in study.
lung b.a.s.e.s. 4 life mobile low-dose computed tomography (ldct) screening: ages 40-54

Conditions: Lung Neoplasms; Lung Cancer

Summary: low-dose ct screening has been shown in two large trials in the united states (nlst) and europe (nelson) to increase overall survival in subjects 55 years of age and older with a strong smoking history. unfortunately, in both north carolina (nc) and south carolina (sc), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. this study is aimed at decreasing the minimum age of screening in a high-risk population.

the primary objective of this study is to evaluate the lung cancer diagnosis rate in individuals 40-54 years of age at their first screening (t0) with mobile low-dose ct. secondary objectives include evaluating the lung cancer diagnosis rate in individuals 40-54 years of age at subsequent screening visits (t1 and t2); evaluating the positive screening rate at t0, t1, and t2; evaluating the impact of baseline demographic (including insurance status), socioeconomic, and healthcare-related factors on lung cancer rates and positive screening rates; and summarizing the incidence rate of all types of cancer found with low-dose lung ct during lung cancer screening. enrollment will continue until 174 subjects are identified in the evaluable population with a total of 1160 subjects anticipated to be enrolled and screened.

Eligibility criteria:
inclusion criteria: * subject must meet all the following applicable inclusion criteria to participate in this study: 1. written informed consent and hipaa authorization for release of personal health information. note: hipaa authorization may be included in the informed consent or obtained separately. 2. age 40-54 years at the time of consent. 3. a positive smoking history of greater/equal to 30 pack years and they are either currently smoking or have quit within the last 15 years. 4. ability to read and understand the english and/or spanish language. 5. ability to understand and comply with study procedures for the entire length of the study. exclusion criteria: * subjects meeting any of the criteria below may not participate in the study: 1. known diagnosis of lung cancer in the past 5 years. 2. any known contraindication to having a low-dose ct scan. 3. known pregnancy.

Keywords: screening lung cancer smoking
a pilot study of metabolic effects of omentectomy

Conditions: Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2; Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy; Age 18-64 Years

Summary: protocol summary type of study: pilot, randomized and single center trial test procedure: omentectomy aim 1. determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation we hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation. aim 2. identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study. we hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies. total enrollment number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at new york university medical center will be invited to participate in this study. subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).

inclusion criteria: * patients who consented to undergo lagb for weight loss and consent to participate in this study * bmi ≥35 kg/m2 * confirmed t2dm treated with oral agents and/or only diet therapy * age 18-64 years exclusion criteria: * insulin therapy * weight change (\>2% body weight) within 4 weeks before surgery * patients with t2dm for more than 10 years research design- pilot study event week (approximate) medical screening (in conjunction with routine pre-op visit) -4 ogtt \& randomization -2 preliminary genetic testing for the future study (blood sample) -2 surgery with or without omentectomy 0 preliminary genetic testing for the future study (fat sample) 0 weight stabilization visit (in conjunction with routine post-op visit) 2 weight stabilization visit (in conjunction with routine post-op visit) 4 ogtt 6 study plan study has approved by irb, nyu school of medicine committee, gcrc, and bellevue hospital. study initiation date: november 01, 2007 enrollment period: nov. 2007 to nov. 2008 study period: nov. 2007 to jan 2008

Eligibility criteria:
inclusion criteria: * patients who consented to undergo lagb for weight loss and consent to participate in this study * bmi ≥35 kg/m2 * confirmed t2dm treated with oral agents and/or only diet therapy * age 18-64 years exclusion criteria: * insulin therapy * weight change (\>2% body weight) within 4 weeks before surgery * patients with t2dm for more than 10 years

Keywords: dm
seated - standing passage of the hemiplegic

Conditions: Hemiplegia

Summary: this is a study for a new mechanical transport device adapted to the hemiplegic patients. healthy volunteers : after explaining the protocol and presenting the movement laboratory, the subjects are equipped with reflective markers on the 4 limbs, the trunk and the head. the subjects are installed on a seat positioned in front of 2 force platforms installed on the ground. the seat is equipped with a force platform. phase 1 : after being seated, the subject realizes : * 3 seat to stand and stand to seat without assistance * 3 seat to stand and stand to seat using a handle located in front of it (handle equipped with a 6-axis force sensor) * 3 seat to stand and stand to seat using the experimental device this phase will last 45minutes (mn) (30mn of equipment and 15mn of sitting passengers standing) phase 2: after being seated, the subject performs a course comprising: * a standing pass from sitting on a chair * a straight line movement * a succession of left and right turns * an upward and downward travel of less than 1%. * standard doorway * standing on the toilet * a sitting pass from the toilet * one way to a bed * a sitting pass on the bed * a passenger seat sitting upright from the bed * a return to the starting point * a sitting pass on the starting chair each stage is timed. a subjective analysis of each step is done by a lickert scale on the perceived comfort and safety. this phase 2 will last 30mn (15mn of course and 15mn of questions). hemiplegic subjects : at each session, the subject is examined by a physician who evaluates the motor control (fugl meyer scale), the equilibrium (berg scale) and the spatial hemineglect (bergego scale). phase 1 is performed except the 3 seat to stand and stand to seat without assistance which are impossible. phase 2 is performed. an evaluation of the device over 4 hours is carried out for each subject in therapeutic apartment in simulated living conditions. the validation in living lab is carried out by an ergonomist and by a questionnaire on the comfort and safety of the various steps identified by the ergonomist.


Eligibility criteria:
inclusion criteria: healthy volunteers : * aged 18-75 years * subject having given his consent * free from any neurological or cardiorespiratory locomotor pathology that may interfere with standing seated passages. hemiplegic patients : * left hemiplegia in one of the following groups : * walking with difficulty or not walking and able to stand with a stick or an armrest * walking difficult or not walking and unable to stand with a cane or an armrest. * aged 18-90 years * subject having given his consent * subjects with a trunk balance to sit without support exclusion criteria: * aged less than 18 or more than 75 (healthy volunteers) or more than 90 (hemiplegic subjects) * pain during seated-standing passages * unstable medical condition * unable to consent * subject under legal protection * left-hemineglect making standing or seated (wheelchair) displacements impossible autonomously (for hemiplegic patients)

Keywords: hemiplegia transport device